AccessGUDID - DEVICE: LAP-BAND System Access Port II Kit (10811955020091)

GUDID

Device Identifier (DI) Information

Brand Name: LAP-BAND System Access Port II Kit
Version or Model: B-2103
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: B-2103
Company Name: Apollo Endosurgery, Inc.

Primary DI Number: 10811955020091
Issuing Agency: GS1
Commercial Distribution End Date: February 28, 2015
Device Count: 1
Labeler D-U-N-S® Number*: 625064352 *Terms of Use

Device Description: ACCESS PORT II KIT

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47065	Gastric band access port kit	A collection of sterile devices designed to establish a replacement access port for an implanted gastric band of the adjustable type that is invasively inflated. It typically includes access port needles, an access port, an end plug, a connector, and tubing to connect the new port to the existing gastric band. It is typically used when the original port must be removed due to leaks, infection, or contamination. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LTI	Implant, Intragastric For Morbid Obesity

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 9.75/10.0 cm

Device Record Status

Public Device Record Key: 5a3e8f79-0728-4c15-a76d-1f92099f4e4d
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 26, 2014